FDA 101
This federal agency oversees the approval of drugs, devices, and biologics in the United States.
What is the FDA?
This person holds ultimate responsibility for the conduct of a clinical trial at a site.
Who is the Principal Investigator? (PI)
This document explains the purpose, risks, benefits, and alternatives of a study to a potential participant.
What is the Informed Consent Form?
This term describes a participant who receives a fake treatment with no active ingredients.
What is a placebo?
This person is OHRI's HRO HeRO.
Who is Mimi?
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This type of FDA application is used to seek approval for a new pharmaceutical drug.
What is an NDA? (New Drug Application)
This staff member manages day-to-day trial operations, including enrollment, data entry, and regulatory binders. (And so much more!)
Who is the Clinical Research Coordinator? (CRC)
DAILY DOUBLE!!
According to federal regulations, informed consent must be obtained BEFORE this happens
What is any study procedure or intervention?
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In this study design, neither the participant nor the investigator knows which treatment group the participant is in.
What is a double-blind study?
This is the OHRI anniversary we are celebrating.
What is 20th?
Before a drug can be tested in humans, sponsors must submit this document to the FDA. Similarly, before a device can be tested in humans, sponsors must submit this document to the FDA (provide one).
What is an IND application? OR What is an IDE application?
This organization or company funds and designs the clinical trial and submits the IND to the FDA.
Who is the Sponsor?
This is the email where OHRI associates are to submit their completed informed consent forms. FORMAT MATTERS!
What is OHRI-ICF-Quality-Reviewers?
This is the process of randomly assigning participants to treatment or control groups to reduce bias.
What is Randomization?
Heart & Vascular, Neuro, Trauma, Oncology, Lipid
What are OHRI Service Lines?
This FDA regulation (21 CFR Part ) governs Good Clinical Practice for human subject research.
These organizations contract with sponsors to perform clinical trial functions on their behalf.
What are Contract Research Organizations? (CROs)
This signature line is utilized when the subject cannot read or write.
What is the witness line?
This document defines the study objectives, design, methodology, and statistical considerations of a clinical trial.
What is the protocol?
614-566-1286
What is OHRI's FAX number?
This trial phase occurs AFTER FDA approval and monitors long-term safety in a broad real-world population.
What is Phase IV (post-marketing surveillance)?
This independent committee reviews and approves clinical trial protocols to protect the rights and welfare of participants.
What is an Institutional Review Board? (IRB)
Informed Consent Forms should be submitted for OHRI review within this timeframe.
What is 24-48 hours?
Established before a study begins, this is a strictly defined, measurable outcome used to determine if an intervention, treatment, or exposure is effective and/or safe.
What is an endpoint?
This was OHRI's first service line.
What is Heart & Vascular? (If this is wrong feel free to blame Kevin)
DAILY DOUBLE!!